Randomized Controlled Trial of Intranasal Ketamine vs. Intranasal Midazolam in Individuals With OCD

Phase 2

Terminated

Brief Summary: Obsessive-compulsive disorder (OCD) is a common illness that causes significant distress and impairment. Currently, serotonin reuptake inhibitors (SRIs) are the only medications that are FDA-approved to treat OCD. Unfortunately, SRIs can take a long time to work (2-3 months), and even then they usually only partially reduce OCD symptoms. The present study, will test if intranasal ketamine is feasible to use and can reduce OCD symptoms significantly more than a comparison medication called midazolam. Therefore, you may or may not receive ketamine as part of this study. Results from this study will allow doctors and researchers to better understand if you and others with OCD may respond to this class of medications.

Recruitment & Eligibility

Inclusion Criteria

Age 18-55
Physically healthy and not currently pregnant
Primary diagnosis of OCD
Sufficient severity of symptoms
For all patients on medications, medications dose must be stable for at least 6 weeks prior to enrollment. Must discuss with Dr. current medications and doses.
Able to provide consent

Exclusion Criteria

First degree relative with schizophrenia
Psychiatric conditions that would make participation unsafe determined by study doctor
Female patients who are either pregnant or nursing
Planning to start EX/RP during the period of the study or those who have completed an adequate dose of EX/RP (defined as 8 or more sessions within 2 months) within 8 weeks prior to enrollment.
Nasal obstruction or history of nasal surgery
Currently on psychotropic medication or other medication likely to interact with the glutamate system
Medical conditions that make participation unsafe
Allergy or intolerance to ketamine or midazolam

Arm && Interventions

Group	Intervention	Description
Midazolam	Intranasal Midazolam	A single dose of intranasal midazolam up to 4 mg
Ketamine	Intranasal Ketamine	A single dose of intranasal ketamine up to 50 mg

Primary Outcome Measures

Name	Time	Method
Number of Patients Who Met and Exceeded Response Criteria of Yale-Brown Obsessive-Compulsive Scale.	Baseline and 1 Week	Patients given YBOCS (Yale Brown Obsessive-Compulsive Scale), a gold standard measure of obsessions and compulsions. For the YBOCS the minimum units are 0 and Maximum units on the total scale are 40. The higher the number on the YBOCS, the more severe the symptoms. Response was defined as at least a 35% reduction on the YBOCS.

Secondary Outcome Measures